*Unravelling the effectiveness of a behaviour change intervention to enhance physical activity in nurse-led cardiovascular risk management: study protocol of a clustered-randomized controlled trial in primary care*

Completed

• Conditions: cardiovasculair risico; at risk for heart and vessel disease; cardiovascular risk

• Registration Number: NL-OMON45037
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 277

Inclusion Criteria

Eligible patients have at least one of the following risk factors of cardiovascular risk management according to the Dutch guideline for Cardiovascular risk management: ;Aged 40-75;AND
* 1 of the following criteria ;1. have a high blood pressure (* 140 mmHg) or are already treated for high blood pressure
2. have a high total cholesterol (* 6.5 mmol/l) or already treated for high cholesterol
3. have diabetes mellitus type 2 (DM2)
4. have a positive family history of CVD;AND;Not adhere to the Dutch Norm for Healthy Exercise according to a self-reported questionnaire

Exclusion Criteria

- Have participated in a program to increase their level of physical activity in the past 2 years.
- Are unable to give informed consent (eg. due to cognitive impairment)
- Are unable to speak, write and read Dutch
- Have contra-indications to increase their physical activity level (eg. unstable angina
pectoris, unstable heart failure, acute illness)
- Have a terminal illness
- Have severe psychiatric illness or chronic disorder(s) that seriously influence the ability to improve their psychical activity level

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is level of physical activity measured with the Personal<br /><br>Activity Monitor.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are sedentary behaviour, self-efficacy for physical<br /><br>activity, patient activation and health status (EQ-5D). Potential<br /><br>patient-related effect modifiers are age, body mass index, level of education,<br /><br>social support, anxiety and depressive symptoms, patient-provider relationship<br /><br>and baseline amount of minutes of physical activity. Furthermore a process<br /><br>evaluation will be conducted to evaluate the fidelity, dose and reach of the<br /><br>Activate intervention, identify barriers and facilitators for implementation,<br /><br>and to assess the satisfaction of participants. Data will be collected at<br /><br>baseline, at 3 months of follow up and at 6 months of follow up. </p><br>